As part of the HealthTech Charter series, this article delves into the Second Best Practice on the Reuse and Access to Secondary Health Data. Find out what leading entrepreneurs have identified as the most empowering practice to scale their solutions within Europe.  

Health data replaces guess work. It empowers researchers, patients, and clinicians to make informed decisions based on real-world cases. Access to secondary health data is a key enabler in the development of innovative solutions in healthcare. However, the lack of common standards across Europe and diverging national regulations often makes accessing secondary health data extremely complex. This, in turn, hinders digital health technologies and solutions from reaching their full potential.

Secondary health data refers to aggregated data from population-level sources – such as electronic health records, health surveys, and health trails – which can be anonymised to optimise population health, create more efficient healthcare systems, and foster innovation. To fully exploit the potential of health data, data quality and interoperability are key features for its access and use. 

Although many national health data ecosystems in Europe are maturing to support secondary use of health data, cross-border initiatives are still fragmented. Significant work is needed to establish stronger health-data ecosystems and infrastructures for reusing data across Europe. The European Commission’s development of the European Health Data Space (EHDS) serves as a platform where data can be shared operationally with the full protection of citizens’ interests and rights while promoting research and innovation through secondary use of health data. The legislative proposal on EHDS is set to be released at the beginning of April, see more on our position here. 

At a national level, Finland has pioneered health-data regulation by laying down the Act on the Secondary Use of Health and Social Data. This legislation provides a GDPR-compliant, legal basis for health data access and processing, facilitating secure and effective data reuse. This has streamlined developments in health research and innovation – such as the FinnGen initiative, a personalised medicine research project combining genome information with digital health care data. The composition of Finland’s health data act serves as a legal prototype of what currently works to empower digital health entrepreneurs, such as Kaiku and Medixine, in their research and innovation. 

As defined in the HealthTech Charter, Finland’s act on Health Data underpins one of Europe’s best examples of data legislation. Adopting similar practises across European borders would be a big step towards building an open and trusted health-data ecosystem that could help Europe nations respond to the many urgent challenges facing its society and economy today. Let’s push the conversation forward as we continue building Europe into a leading hub for digital health innovation. 

Interested in having a conversation or collaborating in the HealthTech Charter project? Don’t hesitate to reach out to us here!